Metrology & Certification of Medical Equipment

Lecturer:

Tutor:

Supervisor:

Department of Biomedical Technology

Synopsis:

System of metrology and relevant legislation. Systems of units, quantities and standarts. International systems. Medical devices and metrology. EU directives relevant to the medical devices. International documents and technical norms relevant to the medical device metrology. Medical device certification. Measurement errors and uncertainties. Biosystem measurement models. Uncertainties during calibration.

Requirements:

Attendance at seminars:

Each seminar 1 item

Maximum13 items

Presentation of required method application:

0- 7 items

Maximum 7 items

Through test:

0-30 items

Ordinarily 25 items

Final test:

0- 50 items

Ordinarily 40 items

Seminar work:

0-20 items

Ordinarily 15 items

Fully - maximum:

100 items

Syllabus of lectures:

1.The law of metrology. The national metrology system.

2.The system of law and technical rules determinative authority position of state administration and others subjects.

3.The system as komplex of facilities and equipments. The fundamental metrology, legal metrology, industrial metrology.

4.The global metrology system. International cooperation: metric convention, EUROMET, MRA, OIML, WELMEC.

5.The health care equipment and metrology. The directives EU relating to explicit test gear. International documents and technical standards relative to metrology of health care equipment. Certification of health care equipment.

6.Uncertainties and connections to international rules. Biomeasuring errors. Uncertainties of biomeasuring, types of uncertainties.

7.Standards uncertainties by direct measurement. The rules of uncertainties propagation. Measurement models by biosystems. Calibration uncertainties and meter verification.

Syllabus of tutorials:

1.Structure of juridical and technical rules in the sphere of healthcare equipment metrology. Metrological system as complex of facilities and equipments.

2.Force basic area of metrological system in healthcare establishments: fundamental metrology, legal metrology, healthcare metrology, metrology focused on meter's maintenance in healthcare establishments, metrology ensuring background for high quality of services in diagnose and therapy.

3.Global metrological system, international cooperation, international documents and technical rules of healthcare equipment metrology.

4.Uncertainties of a bio measurement, types of uncertainties, input value standard uncertainties interpretation by A method and B method, combined and extended uncertainties, sources of uncertainties.

5.Standard uncertainties determination during in a direct measurement. Standard uncertainties calculation, examples of correlation sources in sequence to correlation source. Measurement models on biosystems. Uncertainties in meters calibration and verification.

6.Hospital metrological regulations and its incorporation to the system of a quality management. Discretions and duties of a hospital metrology staff.

7.Presentation of student's semestral works.

Study Objective:

The goal of this subject is to inform students about theory of the metrology and the certification by the health care equipment and its related legislature.

Study materials:

[1] Guide to the Expression of Uncertainty of Measurements, ISO, Ženeva, 1993

[2] IEC 60359:2001; „Electrical and electronic measurement equipment - Expression of performance“

Note:

Further information:

No time-table has been prepared for this course

The course is a part of the following study plans: